Fibroblast Growth Factor 23 and Sclerostin in Relation to Calcium in COVID-19 Patients

An observational study of COVID-19, run by Aswan University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Hypocalcemia is associated with COVID-19 patients and is linked to poor prognosis, Fibroblast growth factor 23 (FGF23) and Sclerostin inhibit vitamin D activation and are linked to hypocalcemia. Levels of FGF23 and Sclerostin in COVID-19 patients will be detected and correlated to calcium levels. Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Calcium, Fibroblast growth factor 23 and Sclerostin
How many people: 66 participants
Where: 1 siteEgypt
Study dates: 1 May 2022to 1 Feb 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Study population: (Group A): Mild to moderate COVID 19 patients. (Group B): Severe to critical COVID 19 patients. (Group C): Normal male subjects (Control)

Who may be able to join

Positive COVID 19 (Mild to moderate - severe to critical).

Who cannot join

known diagnosis of CKD.
Known parathyroid disease.
Use of phosphate binder therapy within the past 3 months.
Use of calcium therapy within the past 3 months
Treatment with 25(OH) vitamin D or 1,25 (OH)(2) D
Underlying metabolic bone disease.
Underlying renal phosphate wasting disorder.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Aswan University hospital
Aswān, 81511

Other trials in Egypt

About this study

Official title: Serum Levels of Fibroblast Growth Factor 23 and Sclerostin in Relation to Serum Calcium Level in COVID 19 Patients

Hypocalcemia is associated with COVID-19 patients and is linked to poor prognosis, Fibroblast growth factor 23 (FGF23) and Sclerostin inhibit vitamin D activation and are linked to hypocalcemia.

Levels of FGF23 and Sclerostin in COVID-19 patients will be detected and correlated to calcium levels.

Read the detailed description

COVID 19 is a current worldwide pandemic caused by severe acute respiratory syndrome coronavirus 2 "SARS-CoV-2". Hypovitaminosis D and hypocalcaemia have been reported to be associated with COVID 19 infection, they are considered good biomarkers of clinical severity of COVID 19. Poor prognosis related to hypocalcemia is increased in elderly patients.

Fibroblast growth factor 23 and sclerostin are secreted from the bone, they decrease active vitamin D levels. Their levels and their relation to calcium levels in COVID-19 patients will be detected.

Conditions: COVID-19
Being tested: Calcium, Fibroblast growth factor 23, Sclerostin, parathyroid hormone
Keywords: COVID-19, Hypocalcemia, Fibroblast growth factor 23 (FGF23), Sclerostin
Medical subject headings: COVID-19, Hypocalcemia, Sclerosteosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CalciumDiagnostic test
Free calcium serum levels
Fibroblast growth factor 23Diagnostic test
Serum level
SclerostinDiagnostic test
Serum level
parathyroid hormoneDiagnostic test
serum level

Study groups in NCT05275491
Study group	Role	What they receive
Mild to moderate COVID 19 patients		According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Mild illness that show symptoms like fever, cough, nausea, vomiting, sore throat, loss of taste \& smell but don't show dyspnea or abnormal chest imaging. Moderate illness that show clinical or radiological lower respiratory disease with SpO2 > 94% on room air. Receives: Diagnostic Test: Calcium; Diagnostic Test: Fibroblast growth factor 23; Diagnostic Test: Sclerostin; Diagnostic Test: parathyroid hormone
Severe to critical COVID 19 patients		According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Severe illness that show SpO2 < 94% on room air, (PaO2/FiO2) <300 mm Hg \& lung infiltration > 50% with respiratory rate > 30 breath/min. Critical illness that show respiratory failure, septic shock or multiorgan failure. Receives: Diagnostic Test: Calcium; Diagnostic Test: Fibroblast growth factor 23; Diagnostic Test: Sclerostin; Diagnostic Test: parathyroid hormone
Normal male subjects (Control)		Not described Receives: Diagnostic Test: Calcium; Diagnostic Test: Fibroblast growth factor 23; Diagnostic Test: Sclerostin; Diagnostic Test: parathyroid hormone

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in serum calcium levels
Expected lower serum calcium levels in COVID 19 patients compared to control
Measured: 6 months
changes in FGF23 levels
Expected higher FGF23 levels in COVID 19 patients compared to control
Measured: 6 months
changes in sclerostin levels
Expected higher sclerostin levels in COVID 19 patients compared to control
Measured: 6 months
Changes in parathyroid hormone levels
Expected lower levels in COVID 19 patients compared to control
Measured: 6 months

Secondary outcomes (2)

Relation between FGF 23 and calcium levels
A negative relation is expected
Measured: 6 months
Relation between sclerostin and calcium levels
A negative relation is expected
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20221 Feb 2023

First posted11 Mar 2022
Study start1 May 2022
Primary completion1 Jan 2023
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05275491
Sponsor's protocol ID: FGF23 in COVID-19
Status last verified: Feb 2023
First submitted: 10 Mar 2022
Last updated: 14 Feb 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
PubMed 32150360
Zhou X, Chen D, Wang L, Zhao Y, Wei L, Chen Z, Yang B. Low serum calcium: a new, important indicator of COVID-19 patients from mild/moderate to severe/critical. Biosci Rep. 2020 Nov 30;40(12):BSR20202690. doi: 10.1042/BSR20202690. Online ahead of print.
PubMed 33252122
Demir M, Demir F, Aygun H. Vitamin D deficiency is associated with COVID-19 positivity and severity of the disease. J Med Virol. 2021 May;93(5):2992-2999. doi: 10.1002/jmv.26832. Epub 2021 Feb 9.
PubMed 33512007
di Filippo L, Doga M, Frara S, Giustina A. Hypocalcemia in COVID-19: Prevalence, clinical significance and therapeutic implications. Rev Endocr Metab Disord. 2022 Apr;23(2):299-308. doi: 10.1007/s11154-021-09655-z. Epub 2021 Apr 13.
PubMed 33846867
Lewiecki EM. Role of sclerostin in bone and cartilage and its potential as a therapeutic target in bone diseases. Ther Adv Musculoskelet Dis. 2014 Apr;6(2):48-57. doi: 10.1177/1759720X13510479.
PubMed 24688605
Quarles LD. Role of FGF23 in vitamin D and phosphate metabolism: implications in chronic kidney disease. Exp Cell Res. 2012 May 15;318(9):1040-8. doi: 10.1016/j.yexcr.2012.02.027. Epub 2012 Mar 7.
PubMed 22421513

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Serum Levels of Fibroblast Growth Factor 23 and Sclerostin in Relation to Serum Calcium Level in COVID 19 Patients
ClinicalTrials.gov ID: NCT05275491
Acronym / sponsor ID: FGF23 in COVID-19
Conditions: COVID-19
Keywords: COVID-19, Hypocalcemia, Fibroblast growth factor 23 (FGF23), Sclerostin
Study type: Observational
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Aswan University HospitalUniversity, hospital or other
Study start: 1 May 2022 (actual)
Primary completion: 1 Jan 2023 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 11 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypocalcemia is associated with COVID-19 patients and is linked to poor prognosis, Fibroblast growth factor 23 (FGF23) and Sclerostin inhibit vitamin D activation and are linked to hypocalcemia.

Levels of FGF23 and Sclerostin in COVID-19 patients will be detected and correlated to calcium levels.

Detailed description

Fibroblast growth factor 23 and sclerostin are secreted from the bone, they decrease active vitamin D levels. Their levels and their relation to calcium levels in COVID-19 patients will be detected.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
Mild to moderate COVID 19 patients	–	Diagnostic Test: Calcium, Diagnostic Test: Fibroblast growth factor 23, Diagnostic Test: Sclerostin, Diagnostic Test: parathyroid hormoneAccording to COVID 19 treatment guidelines of National Institutes of Health (NIH): Mild illness that show symptoms like fever, cough, nausea, vomiting, sore throat, loss of taste \& smell but don't show dyspnea or abnormal chest imaging. Moderate illness that show clinical or radiological lower respiratory disease with SpO2 > 94% on room air.
Severe to critical COVID 19 patients	–	Diagnostic Test: Calcium, Diagnostic Test: Fibroblast growth factor 23, Diagnostic Test: Sclerostin, Diagnostic Test: parathyroid hormoneAccording to COVID 19 treatment guidelines of National Institutes of Health (NIH): Severe illness that show SpO2 < 94% on room air, (PaO2/FiO2) <300 mm Hg \& lung infiltration > 50% with respiratory rate > 30 breath/min. Critical illness that show respiratory failure, septic shock or multiorgan failure.
Normal male subjects (Control)	–	Diagnostic Test: Calcium, Diagnostic Test: Fibroblast growth factor 23, Diagnostic Test: Sclerostin, Diagnostic Test: parathyroid hormone

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: (Group A): Mild to moderate COVID 19 patients. (Group B): Severe to critical COVID 19 patients. (Group C): Normal male subjects (Control)

Key inclusion criteria (1 listed)

Positive COVID 19 (Mild to moderate - severe to critical).

Key exclusion criteria (7 listed)

known diagnosis of CKD.
Known parathyroid disease.
Use of phosphate binder therapy within the past 3 months.
Use of calcium therapy within the past 3 months
Treatment with 25(OH) vitamin D or 1,25 (OH)(2) D

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CalciumFree calcium serum levels	Diagnostic test	Mild to moderate COVID 19 patients, Normal male subjects (Control), Severe to critical COVID 19 patients
Fibroblast growth factor 23Serum level	Diagnostic test	Mild to moderate COVID 19 patients, Normal male subjects (Control), Severe to critical COVID 19 patients
SclerostinSerum level	Diagnostic test	Mild to moderate COVID 19 patients, Normal male subjects (Control), Severe to critical COVID 19 patients
parathyroid hormoneserum level	Diagnostic test	Mild to moderate COVID 19 patients, Normal male subjects (Control), Severe to critical COVID 19 patients

Primary outcome

Changes in serum calcium levels
Time frame: 6 months
Expected lower serum calcium levels in COVID 19 patients compared to control
changes in FGF23 levels
Time frame: 6 months
Expected higher FGF23 levels in COVID 19 patients compared to control
changes in sclerostin levels
Time frame: 6 months
Expected higher sclerostin levels in COVID 19 patients compared to control
Changes in parathyroid hormone levels
Time frame: 6 months
Expected lower levels in COVID 19 patients compared to control

2 secondary outcomes

Relation between FGF 23 and calcium levels
Time frame: 6 months
Relation between sclerostin and calcium levels
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
Background: PubMed 32150360Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
Background: PubMed 33252122Zhou X, Chen D, Wang L, Zhao Y, Wei L, Chen Z, Yang B. Low serum calcium: a new, important indicator of COVID-19 patients from mild/moderate to severe/critical. Biosci Rep. 2020 Nov 30;40(12):BSR20202690. doi: 10.1042/BSR20202690. Online ahead of print.
Background: PubMed 33512007Demir M, Demir F, Aygun H. Vitamin D deficiency is associated with COVID-19 positivity and severity of the disease. J Med Virol. 2021 May;93(5):2992-2999. doi: 10.1002/jmv.26832. Epub 2021 Feb 9.
Background: PubMed 33846867di Filippo L, Doga M, Frara S, Giustina A. Hypocalcemia in COVID-19: Prevalence, clinical significance and therapeutic implications. Rev Endocr Metab Disord. 2022 Apr;23(2):299-308. doi: 10.1007/s11154-021-09655-z. Epub 2021 Apr 13.
Background: PubMed 24688605Lewiecki EM. Role of sclerostin in bone and cartilage and its potential as a therapeutic target in bone diseases. Ther Adv Musculoskelet Dis. 2014 Apr;6(2):48-57. doi: 10.1177/1759720X13510479.
Background: PubMed 22421513Quarles LD. Role of FGF23 in vitamin D and phosphate metabolism: implications in chronic kidney disease. Exp Cell Res. 2012 May 15;318(9):1040-8. doi: 10.1016/j.yexcr.2012.02.027. Epub 2012 Mar 7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Asmaa Abdelmageed Muhammed, Lecturer principal investigator

Aswan University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Aswan University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in serum calcium levels (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05275491, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.